| NDC Code | 49281-519-25 |
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| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-519-25) / .25 mL in 1 SYRINGE, GLASS (49281-519-00) |
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| Product NDC | 49281-519 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone Quadrivalent Northern Hemisphere |
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| Non-Proprietary Name | Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/kansas/14/2017 X-327 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20190701 |
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| Marketing Category Name | BLA |
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| Application Number | BLA103914 |
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| Manufacturer | Sanofi Pasteur Inc. |
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| Substance Name | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
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| Strength | 7.5; 7.5; 7.5; 7.5 |
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| Strength Unit | ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL |
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